Phase II Study Comparing LR-GEM to R-GEM-P in Second-line Treatment of Diffuse Large B-cell Lymphoma (LEGEND)
NCT02060656 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92
Last updated 2019-09-19
Summary
This is a randomised, phase II open-labelled two-arm study comparing R-GEM-P and LR-GEM in second-line treatment of Diffuse Large B-cell lymphoma. Eligible patients will be randomised 1:1 between R-GEM-P and LR-GEM.
Conditions
- Diffuse Large B-Cell Lymphoma
Interventions
- DRUG
-
1000mg/m2 IV D1, D8, D15 every 28 days
- DRUG
-
Methylprednisolone
1000mg/m2 IV or PO D1-5 every 28 days
- DRUG
-
375mg/m2 IV D1, D15 every 28 days
- DRUG
-
100mg/m2 IV D15 every 28 days
- DRUG
-
25mg PO D1-21 every 28 days
Sponsors & Collaborators
-
Celgene Corporation
collaborator INDUSTRY -
Royal Marsden NHS Foundation Trust
lead OTHER
Principal Investigators
-
David Cunningham, MD FRCP · Royal Marsden NHS Foundation Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2018-02-28
- Completion
- 2023-08-31
Countries
- United Kingdom
Study Locations
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